ClearanceBrief
Panels › General, Plastic Surgery › Product code FXX · Class 2

Mask, Surgical

Regulation 878.4040

7510(k)s in 12 months (607 all time)
0recalls in 12 months (12 all time)
10recalls that name a 510(k)
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Top companies in FXX

Company510(k)sRecalls
Tecnol New Jersey Wound Care, Inc.110
Owens & Minor (O&M) Halyard, Inc.80
Anago, Inc.70
Protectaide, Inc.70
3M Company60
Guangdong Kingfa Sci. & Tech.Co., Ltd.60
AMD Medicom Inc.05
Tecnol Medical Products, Inc.50
Dukal Corp.40
Kimberly-Clark40
Decided510(k)Device and applicantCode
Jun 10, 2021K203756Disposable Surgical Mask
Lucky Textile Industrial(Wuxi) Co., Ltd., CN
FXX
Jun 8, 2021K211062Medical Face Mask
Ammex-Weida (Hubei) Health and Safety Products Co., Ltd., CN
FXX
Jun 8, 2021K202126Disposable Surgical Mask
Shenzhen Peninsula Medical Co., Ltd., CN
FXX
Jun 7, 2021K210641Disposable Medical Mask
Tuosheng Protective Products (Ningbo) Co., Ltd., CN
FXX
Jun 7, 2021K210433Surgical Face Mask (Ear loops and Tie-on)
Wuhan Dymex Healthcare Co., Ltd., CN
FXX
Jun 7, 2021K210372Disposable Surgical Mask
Dongguan Shin YI Healthcare Products Factory, CN
FXX
Jun 7, 2021K202580Disposable Surgical Mask
Qingdao Likangyuan Medical Device Co., Ltd., CN
FXX
Jun 4, 2021K203704Surgical face mask
Juntech(Jiaxing)Healthcare Materials Co,.Ltd, CN
FXX
Jun 4, 2021K203388Disposable medical mask
Everwin Toys (Dongguan)., Ltd., CN
FXX
Jun 3, 2021K202128Allmed Surgical Face Masks (Ear loops)
Allmed Medical Products Co., Ltd., CN
FXX
Jun 2, 2021K211440ASM-301 Level 3 Surgical Mask
American Surgical Mask Company, LLC
FXX
Jun 2, 2021K210429Disposable Surgical Face Mask
Jiangxi Heying Pharmaceutical Co., Ltd., CN
FXX
Jun 2, 2021K210150Disposable Medical mask
Hubei Wanli Protective Products Co., Ltd., CN
FXX
Jun 2, 2021K203190Surgical Face Mask
Rfx+Care Manufactoring Co., Ltd., CN
FXX
May 25, 2021K211275AirMax Procedure Mask
Premiumestore, LLC
FXX
May 20, 2021K202899Procedure Mask, Surgical Mask
Kenpax International Limited, CN
FXX
May 17, 2021K211105Ear-Friendly Mask
Ray Co., Ltd., KR
FXX
May 14, 2021K210302Disposable Medical mask
Anhui Jbh Medical Apparatus Co., Ltd., CN
FXX
May 13, 2021K210815Disposable Face Mask
Biobase Scientific (Shandong) Co., Ltd., CN
FXX
May 13, 2021K202697United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing
United Sewing Automation, Inc.
FXX
May 7, 2021K210218SURGICAL MASK, Model Name:C015
Qingdao Hainuo Biological Engineering Co., Ltd., CN
FXX
May 6, 2021K210705Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3
Defender Safety, Inc.
FXX
May 6, 2021K2025983 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Lo
3A Medical Products Co., Ltd., CN
FXX
May 4, 2021K210304Surgical Mask
Jin Pin Electrical Co., Ltd. Zhuhai S.E.Z., CN
FXX
Apr 29, 2021K202457M1 Surgical Face Mask
CHISON Medical Technologies Co., Ltd., CN
FXX
Apr 28, 2021K210020Medical Mask
Zhende Medical Co., Ltd., CN
FXX
Apr 26, 2021K202647Surgical Mask
Ningbo Green Textile Co., Ltd., CN
FXX
Apr 23, 2021K210030Medical Surgical Mask
Tianjin Aoshang Outdoor Equipment Co., Ltd., CN
FXX
Apr 23, 2021K210007Face Mask
Jinhua Jingdi Medical Supplies Co., Ltd., CN
FXX
Apr 23, 2021K202607Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50
String King Lacrosse, LLC
FXX
Apr 23, 2021K202387Disposable Surgical Face Mask
Guangdong Bida Medical Technology Co., Ltd., CN
FXX
Apr 23, 2021K201853Naton Disposable Surgical Face Mask
Naton Biotechnology (Beijing) Co., Ltd., CN
FXX
Apr 22, 2021K203646Disposable Medical Face Mask
Guangzhou Mei YI Kang Medical Technology Co., Ltd., CN
FXX
Apr 21, 2021K202759Disposable medical surgical mask
Chongqing Coe Display Technology Co., Ltd., CN
FXX
Apr 15, 2021K201718GD Disposable Medical Face Mask
Jiangsu Guangda Medical Material Group Co., Ltd., CN
FXX
Apr 14, 2021K201127DEFEND Ear-loop Face Masks
Young Dental Manufacturing Co. 1, LLC
FXX
Apr 11, 2021K210018Disposable Medical Mask
Diasia Biomedical Technology Co., Ltd., CN
FXX
Apr 11, 2021K203012Surgical Mask
Customfab, Inc.
FXX
Apr 11, 2021K202761Medical Surgical Mask (Non-sterile)
Guangdong Goodfeeling Hygiene Material Tec Co., Ltd., CN
FXX
Apr 9, 2021K202513Disposable Medical Face Mask-Model FM-04
Shenzhen Jinko Industrial Co., Ltd., CN
FXX
Apr 6, 2021K203801Disposable Surgical Face Mask
Anhui Jiabao Protective Equipments Co., Ltd., CN
FXX
Apr 5, 2021K202655Disposable Medical Mask
Dongguan Runlin Medical Supplies Technology Co., Ltd., CN
FXX
Apr 2, 2021K210023Surgical Face Mask
Guangdong Winsun Personal Care Products Co.,Ltd, CN
FXX
Mar 31, 2021K203101Secure Wear USA Surgical Face Mask
Secured Ortho Manufacturing of America, LLC
FXX
Mar 31, 2021K202424Surgical Mask-Models CR02-2, CR02
Foshan Xinbao Technology Co., Ltd., CN
FXX
Mar 30, 2021K202708Surgical Face Masks
Intco Medical(Hk) Co., Ltd., CN
FXX
Mar 30, 2021K201896ivi N3003 Surgical face Mask, ivi N6006 Surgical mask
Iob Medical, Inc.
FXX
Mar 29, 2021K202191Surgical Mask
Wuhan Zonsen Medical Products Co., Ltd., CN
FXX
Mar 26, 2021K203685Disposable Surgical Face Mask
Xiantao Zhongyi Safety & Protection Products Co., Ltd., CN
FXX
Mar 26, 2021K202905Disposable Face Mask
Jiangsu Excellence Medical Supplies Co., Ltd., CN
FXX

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